buprenorphine
- Manufacturer
- PAYLESS COMPOUNDERS, LLC
- Effective date
- 2024-12-11
- Label type
- ANIMAL COMPOUNDED DRUG LABEL
- Version
- 10
- Source
- full-release
- Hydrated at
- 2026-06-01 02:51:18
Label at a glance#
Productbuprenorphine
Active ingredientBUPRENORPHINE HYDROCHLORIDE
Label structure4 sections
Label contents#
Full prescribing information#
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BUPRENORPHINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 68654759-f50b-79ef-24c5-544d94fe7d87 | Product name | 3 | 20251114 |
| 08a295bb-88df-4ab0-a120-a75a789a74f1 | Product name | 1 | 20231013 |
| cb89b86a-369e-4204-8910-ae797c503af3 | Product name | 1 | 20230706 |
| ab841ac7-728a-4fc9-be0a-35b96cecbf39 | Product name | 4 | 20230306 |
| 100316cc-94a9-474e-97ad-9b5c6ddec605 | Product name | 5 | 20230125 |
| 539bc5d3-546b-4af6-9c31-058ce6c459d3 | Product name | 2 | 20220210 |
| b871fccd-1de6-4c7f-b9e5-045304641ee6 | Product name | 8 | 20220118 |
| d4880ace-a516-8c47-8dfd-73a4ba5887d7 | Product name | 2 | 20180830 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 31e16ab2-c562-4617-a3e8-ed285320e16e | Product name | 1 | 20180201 |
| 4c23a34c-e8fc-424c-8fa0-ee064ba6eaef | Product name | 1 | 20170706 |
| a5920611-4285-f024-69b9-39ff338b81ea | Product name | 5 | 20170609 |
| 3df867ed-9d48-45cf-bded-1394beaea0b1 | Product name | 3 | 20161206 |
| 973da5bf-b1f9-4de0-81ee-7ca066c98ca4 | Product name | 1 | 20160712 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70022-001-10 | buprenorphine | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | 10 | |
| 70022-004-10 | buprenorphine | 10 mL in 1 VIAL, MULTI-DOSE | SOLUTION | 10 | 10 | |
| 70022-010-03 | buprenorphine | 30 mL in 1 BOTTLE, PLASTIC | SOLUTION | 30 | 10 | |
| 70022-010-10 | buprenorphine | 100 mL in 1 BOTTLE, PLASTIC | SOLUTION | 100 | 10 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70022-001 | BUPRENORPHINE INJECTION, SOLUTION BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC] | 10 | 1 package rows | 20241213_a1c1f498-e101-467f-b81c-1451c44e7a01.zip |
| 70022-004 | BUPRENORPHINE INJECTION, SOLUTION BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC] | 10 | 1 package rows | 20241213_a1c1f498-e101-467f-b81c-1451c44e7a01.zip |
| 70022-010 | BUPRENORPHINE INJECTION, SOLUTION BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC] | 10 | 2 package rows | 20241213_a1c1f498-e101-467f-b81c-1451c44e7a01.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 38779-0888-0 | GM - Gram | 38779-0888 | ea475beb-91f1-4bce-ba3e-3ec1b988f3f9 | 1 | 2014-09-03 |
| 38779-0888-1 | GM - Gram | 38779-0888 | 3fd81d18-9e25-45de-8c87-ee5e50fce5a8 | 1 | 2014-09-03 |
| 38779-0888-3 | GM - Gram | 38779-0888 | 42cd3e9d-3565-4121-972d-4b8020e22216 | 1 | 2014-09-03 |
| 38779-0888-6 | GM - Gram | 38779-0888 | 356a495c-16ae-4ea4-8c6c-20d53148d9b4 | 1 | 2014-09-03 |
| 38779-0888-9 | GM - Gram | 38779-0888 | 5b7015c7-96d3-4be2-bb53-082d7a263986 | 1 | 2014-09-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE | ACTIVE INGREDIENT | 56W8MW3EN1 | 1 | |
| BUPRENORPHINE | ACTIVE MOIETY | 40D3SCR4GZ | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- buprenorphine
- BUPRENORPHINE HYDROCHLORIDE
- ANHYDROUS DEXTROSE
- MANNITOL
- WATER
- HYDROCHLORIC ACID
- BENZYL ALCOHOL
- METHYLPARABEN
- PROPYLPARABEN
- SUCROSE
- SODIUM BENZOATE
- ANHYDROUS CITRIC ACID
- SODIUM CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70022-001 | 70022-001-10 |
| 38779-0888 | |
| 70022-004 | 70022-004-10 |
| 70022-010 | 70022-010-03, 70022-010-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / ORAL | 388 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE / ORAL | 7 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO, SUSPENSION / TOPICAL | 0.15 %w/w | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INFILTRATION | 0.35 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SPONGE / TOPICAL | NA | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION / ORAL | 320 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | FILM / BUCCAL | 0.22 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAVENOUS | 95 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / EPIDURAL | 30 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, EXTENDED RELEASE / ORAL | 0.17 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUPPOSITORY / RECTAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | ENEMA / RECTAL | 0.18 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAVENOUS | 45 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / NASAL | 140 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION, EMULSION / INTRAVENOUS | 0.1 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION/ DROPS / OPHTHALMIC | 0.01 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / VAGINAL | 3 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY / TOPICAL | 0.01 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION / INTRAVENOUS | 864 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET / ORAL | 1.8 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | GEL / TOPICAL | 3 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INFILTRATION | 80 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | EMULSION / TOPICAL | 0.2 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ENEMA / RECTAL | 0.02 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET, COATED / ORAL | 0.8 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | LOTION / TOPICAL | 140 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE, EXTENDED RELEASE / ORAL | 0.22 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET / ORAL | 30 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRAMUSCULAR | 6 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | POWDER, FOR SOLUTION / ORAL | 123 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GEL / DENTAL | 0.08 %w/w | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 414 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / TOPICAL | 0.1 %w/v | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CONCENTRATE / INTRAVENOUS | ADJ PH | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / OPHTHALMIC | 0.01 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PARENTERAL | 18 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | AEROSOL / TOPICAL | 0.08 %w/w | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SYRUP / ORAL | 80 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | ELIXIR / ORAL | 5.02 mg/5ml | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.02 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GEL / RECTAL | 406 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | FILM, SOLUBLE / BUCCAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION, CONCENTRATE / ORAL | 1 mg/1ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUPPOSITORY / VAGINAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | LIQUID / INTRAVENOUS | 18 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 15 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / ORAL | 1 mg/1ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / ORAL | 100 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| buprenorphine hydrochloride | BUPRENORPHINE HYDROCHLORIDE | Advagen Pharma Ltd | 699638dd-3a53-445f-a545-d0e6eabfe1c9 | 2026-07-17 | Warnings, Adverse reactions | BUPRENORPHINE HYDROCHLORIDE |
| Buprenorphine | BUPRENORPHINE | REMEDYREPACK INC. | aa86a438-1ebf-4c08-bf27-38f1e81efb3a | 2026-07-07 | Warnings, Adverse reactions | Buprenorphine |
| buprenorphine hydrochloride | BUPRENORPHINE HYDROCHLORIDE | REMEDYREPACK INC. | 11686845-f5fd-4e96-8a4f-9b132bf48840 | 2026-07-07 | Warnings, Adverse reactions | BUPRENORPHINE HYDROCHLORIDE |
| BUPRENORPHINE | BUPRENORPHINE | Unit Dose Solutions, Inc. | 5578cd5c-c860-6e8a-e063-6394a90a56c7 | 2026-06-30 | Warnings, Adverse reactions | BUPRENORPHINE |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | aa132031-9d12-45b4-81e0-4a5877661379 | 2026-06-29 | Warnings, Adverse reactions | BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | Bryant Ranch Prepack | 655e3e52-03be-496c-978a-5cffc74b2ae4 | 2026-06-29 | Warnings, Adverse reactions | Buprenorphine |
| BUPRENORPHINE | BUPRENORPHINE | Unit Dose Solutions, Inc. | 5479b218-a388-2c3c-e063-6294a90a0e85 | 2026-06-17 | Warnings, Adverse reactions | BUPRENORPHINE |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | 966adb01-71b4-4e0b-bbc6-b83da9987aa2 | 2026-06-16 | Warnings, Adverse reactions | BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | Major Pharmaceuticals | dba586f9-e3f2-4b9c-849b-907c81a5a0ef | 2026-06-16 | Warnings, Adverse reactions | Buprenorphine |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | bc5a7137-9e8f-438e-84d9-bdbf1db12998 | 2026-06-03 | Warnings, Adverse reactions | BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | Rhodes Pharmaceuticals LLC | 2738feae-316e-426f-971c-5f142ac01b60 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | Buprenorphine |
| Buprenorphine | BUPRENORPHINE | Actavis Pharma, Inc. | 03819118-86f6-4329-adaf-4599e7b71f46 | 2026-05-25 | Warnings, Adverse reactions | Buprenorphine |
| Buprenorphine | BUPRENORPHINE | Teva Pharmaceuticals USA, Inc. | 36995ce3-b515-447b-baa9-aa14f84060d8 | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | Buprenorphine |
| BUPRENORPHINE | BUPRENORPHINE | Rhodes Pharmaceuticals LLC | da90618a-5621-4b15-bc48-9dcc631418de | 2026-05-04 | Warnings, Adverse reactions | BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | INGENUS PHARMACEUTICALS, LLC | 186e3be6-8bc0-4bb9-96f5-429d53632f45 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | Buprenorphine |
| Buprenorphine | BUPRENORPHINE | Aveva Drug Delivery Systems Inc. | 1aae9b13-7431-42ef-8558-14a2325820e6 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | Buprenorphine |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | cd0a90c6-32cc-4114-8573-86ac85503bdf | 2026-04-03 | Warnings, Adverse reactions | BUPRENORPHINE |
| buprenorphine hydrochloride | BUPRENORPHINE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 442831cf-9636-433a-9a12-e9a8cd31f72a | 2026-02-28 | Warnings, Adverse reactions | BUPRENORPHINE HYDROCHLORIDE |
| Buprenorphine | BUPRENORPHINE | Sun Pharmaceutical Industries, Inc. | 9fd1f18f-0b0f-4059-b603-19ecbf0ed63a | 2026-02-11 | Warnings, Adverse reactions | Buprenorphine |
| BUPRENORPHINE | BUPRENORPHINE | A-S Medication Solutions | bfb02ea5-22f2-432e-afc8-f1dbe2ea0614 | 2026-02-06 | Warnings, Adverse reactions | BUPRENORPHINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.



